The Recall Desk
HighFDA (Drugs)·D-0422-2026·Announced 2026-04-15

Cipla lanreotide syringes with safety needle recalled over sterility assurance

Cipla is recalling Lanreotide Injection 120 mg/0.5 mL prefilled syringes supplied with a safety needle, citing lack of assurance of sterility. 54,583 syringes are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a sterile injectable where sterility cannot be assured, a risk of harm with no injuries reported in the source.

Plain-English summary

Cipla USA, Inc. is recalling Lanreotide Injection, 120 mg/0.5 mL, supplied as a box containing one single dose prefilled syringe and one safety needle, NDC 69097-870-67. The product is manufactured by Pharmathen International, S.A. in Rodopi, Greece. The action covers 54,583 syringes.

The stated reason is lack of assurance of sterility, arising from an FDA observation at the contract manufacturing site of deficiencies in its visual inspection procedure. Sterility is a defining requirement of an injectable product. The FDA classified the action as Class II.

Affected lots include 4401666IR1 (exp 8/31/2027) and 4401703IR1, 4401703IR2, 4401704IR1, 4401705IR1, 4401706IR1 and 4401720IR1 (all exp 9/30/2027), with the full list in the recall notice. Distribution was nationwide in the USA.

This is a prescription product supplied to healthcare providers. Patients should not stop a prescribed treatment without medical advice; providers and pharmacies should check stock against the lot numbers in the recall notice and follow the instructions issued by Cipla.

The recalled product

Product
LANREOTIDE ACETATE (LANREOTIDE ACETATE)
Brand
LANREOTIDE ACETATE
Manufacturer
Cipla USA, Inc.
Category
Drug — Injectable solution
Hazard
Affected units
54,583

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot
  • expiry: 4401666IR1
  • Exp 8/31/2027
  • 4401703IR1
  • Exp 9/30/2027
  • 4401703IR2
  • EXP 9/30/2027
  • 4401704IR1
  • 4401705IR1
  • 4401706IR1
  • 4401720IR1
  • 4401721IR1
  • 4401733IR1
  • 4401770IR1
  • 4401777IR1
  • 4401788IR1
  • Exp 10/31/2027
  • 4401804IR1
  • 4401805IR1
  • 4401824IR1

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Cipla USA, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · LANREOTIDE ACETATE

Same manufacturer · Cipla USA, Inc.

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Same hazard · sterility assurance

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